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OpenTrials
Completed

NCT Number: NCT01264796

Community-Based Diabetes Care for Korean American Immigrants

The primary aims are to test the effectiveness of the self-help DM intervention (SHIP-DM), a comprehensive, culturally tailored DM management intervention, in improving glucose outcomes; To determine the effectiveness of the SHIP-DM in KAI with type 2 DM in improving self-care skills and psycho-behavioral outcomes related to DM control, to develop tangible infrastructures for the dissemination of valid and effective education materials to a wider population of KAI with type 2 DM in the US (e.g., audio-visual education materials, web-based intervention materials, mobile telephone-based intervention materials) and to explore the feasibility and acceptability of each dissemination module, utilizing the delayed intervention group participants. The secondary aims are to obtain preliminary cost-effectiveness data related to the proposed intervention, including cost estimates for this type of DM intervention, and to establish a systematic, long-term dissemination plan, including documenting effective methodologies, to facilitate faster translation of research findings and products to direct consumers in non-research settings.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

About this study

Inclusion criteria

  • Self-identified as a first generation Korean American
  • Type 2 diabetes
  • Age 30-75 years
  • Resides in Washington-Baltimore area
  • Self-identified with DM and HbA1c >= 7.0 % within 6 months of screening
  • Expresses willingness to participate in all aspects of the study over its full course

Exclusion criteria

  • Unable to give informed consent
  • Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases)
  • Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia
  • Past experience in diabetes group education

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-identified as a first generation Korean American
  • Type 2 diabetes
  • Age 30-75 years
  • Resides in Washington-Baltimore area
  • Self-identified with DM and HbA1c >= 7.0 % within 6 months of screening
  • Expresses willingness to participate in all aspects of the study over its full course

Exclusion criteria

  • Unable to give informed consent
  • Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases)
  • Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia
  • Past experience in diabetes group education

Treatment and study plan

culturally tailored diabetes education

Behavioral

lifestyle modification group education

Other names: lifestyle modification

Primary outcomes

  1. HbA1c

    Time frame: 12month

    HbA1c level change from baseline comparing with control group

  2. Blood pressure

    Time frame: 12 month

    BP change from baseline comparing with control group

  3. Lipid profile

    Time frame: 12 months

    LDL level change from baseline comparing with control group

  4. quality of life

    Time frame: 12month

    quality of life score change from baseline comparing with control group

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2015
First posted
Dec 22, 2010
Registry last updated
Mar 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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